Business Talk

Ahead of a November deadline, FDA finalizes guidance on waivers, exemptions or exceptions from supply chain security requirements

In a busy week for Drug Supply Chain Security Act (DSCSA) policy updates, the FDA finalized new guidance on waivers, exceptions or exemptions (WEE) from requirements under the DSCSA. The new final guidance provides more clarity on timelines for WEE requests, what the WEE recipient should do to inform its trading partners, and the process for requesting, renewing or terminating WEEs.

The Drug Supply Chain Security Act (DSCSA) and upcoming deadlines

The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

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